Stephanie Sutton

After reviewing the ?shortcomings in quality assurance? that were recently identified at Ben Venue Laboratories?s Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta, Liminity and Vistide. EMA?s Committee for Medicinal Products for Human Use has been reviewing medicines manufactured at Ben Venue since early November 2011, after a joint GMP inspection by FDA and the UK and French medicines regulatory agencies highlighted several problems in the company?s quality-management system, particularly in relation to the sterile filling process and possible particle contamination during manufacturing.

The United Kingdom?s (UK) life-sciences industry this week welcomed a new, multimillion-pound strategy that aims to both support the industry and encourage innovation in the unsettled economic climate.

Elan and the University of Cambridge have launched a center for innovation and drug discovery that will focus on translational research into therapies for Alzheimer?s and Parkinson?s diseases. The Cambridge?Elan Center will be located at the University of Cambridge, and the agreement between the two will last for 10 years. Its goal is to discover novel compounds that can alter the behavior of proteins associated with neurodegenerative disorders and be developed into new treatments.

GlaxoSmithKline is looking to advance the commercialization of scientific innovation in Canada with its launch of the GSK Canada Life Sciences Innovation Fund, which was announced at a GSK-hosted event in Toronto on Nov. 10, 2011. The $50-million national fund will identify strategic investment opportunities in Canada?s life-sciences industry, including academic and health institutions, translational research centers, and start-up companies.

Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, EMA for the first time brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop. According to a press statement, the workshop was designed to enable EMA and attendees to review regulatory and scientific challenges in developing medicines for eye disorders.

GlaxoSmithKline (GSK) has come to a tentative agreement with the US government to conclude ongoing investigations relating to sales and marketing practices. The settlement is still subject to negotiation, but GSK expects to pay around $3 billion, which is covered by existing legal provisions, according to a press statement. The final amount and terms of the settlement are expected to be finalized in 2012. GSK says that the payments will be funded through existing cash resources.

The European Commission has launched an antitrust investigation to examine whether contracts between Johnson & Johnson (J&J) and Novartis were designed to delay the market entry of generic versions of Fentanyl in the Netherlands. Fentanyl, developed by J&J, is a strong painkiller for chronic pain.

The European Commission (EC) has adopted revised proposals clarifying the information that industry can supply to the public on prescription-only medicines, while maintaining a strict ban on direct-to-consumer advertising.

Servier and the Belgium-based biotechnology company Galapagos are embarking on a multiyear strategic alliance to develop new cancer therapies. As a result of the alliance, Galapagos could receive milestone payments of more than EUR 250 million ($332 million).

The latest meeting of EMA?s Committee for Medicinal Products for Human Use (CHMP) has concluded with more than 15 positive opinions for new and generic drugs. Among other important announcements, the agency released a range of concept papers and guidelines for consultation and announced a safety review of orlistat-containing medicines.

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission?s 2010 amended pharmacovigilance legislation.

Pfizer has completed its cash tender offer for the biopharmaceutical company Icagen (Durham, North Carolina) after extending its initial deadline twice. The tender offer of $6 per share was originally scheduled to expire on Aug. 31, 2011, but had to be extended on both Sept. 1 and Sept. 2 after insufficient shares were tendered.

Bayer Healthcare has pledged its support to a Tuberculosis (TB) partnership by providing 620,000 tablets of the antibiotic moxifloxacin to the World Health Organization (WHO), which will make the tablets available to China?s national TB program. In particular, the medicine will be used to fight multidrug-resistant TB.

Pfizer has partnered with the University of California?s San Diego Health Sciences (UCSD) in a drug-discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies. The partnership will leverage UCSD?s expertise in neurosciences, cancer, inflammation, metabolism, clinical pharmacology, HIV, and pain.

The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand. Leaflets will now include less rigid language and new sections that provide greater information about a drug?s benefits. There will also be more information about the medicine?s use in children to comply with the requirements of pediatric regulation.

Bristol-Myers Squibb (BMS) has signed an agreement to acquire Amira Pharmaceuticals, a small-molecule company with a focus on treatments for inflammatory and fibrotic diseases for $325 million. The amount will be paid upfront, but there is potential for additional milestone payments up to $150 million. The acquisition represents BMS?s entrance into the fibrotic diseases area, which the company says is an area of high unmet need.

The European Medicines Agency (EMA) has detailed plans for granting public access to information concerning the potential side effects of medicines. Members of the public will be able to access data in the EudraVigilance database-EMA?s central repository for reports of suspected adverse reactions related to authorized medicines in the European Economic Area, as well as those being studied in clinical trials.

An FDA panel has voted unanimously to withdraw approval for Roche?s Avastin for use in the treatment of metastatic breast cancer because there is not enough data to support the conclusion that the benefits outweigh the risks. The fate of Avastin in this indication now lies in the hands of FDA Commissioner Margaret Hamburg, who will make the final decision after the period for public comments closes at the end of July. Roche will also have the opportunity to submit its final summary on the matter.

Data has highlighted the pharma industry's high rate of Phase III drug terminations and significantly reduced research and development (R&D) spending. According with Thomson Reuters, 2008?2010 saw more than double the number of Phase III terminations compared to 2005?2007, while pharmaceutical R&D spend, in general, hit a three-year low in 2010. The information has been published in the 2011 edition of the Pharmaceutical R&D Factbook, compiled by Thomson Reuters? CMR International unit. A press statement from Thomson Reuters also added that the clinical trials dropout rate is at ?unsustainable levels.?

GlaxoSmithKline (GSK) has entered into an agreement to purchase Shenzhen Neptunus' stake in a previously formed joint venture between the companies involved in the development and manufacture of influenza vaccines in China, Hong Kong, and Macau. GSK will pay Shenzhen Neptunus $39 million, after which GSK will be the sole owner of the joint venture company, Shenzhen GSK-Neptunus Biologicals (GSKNB).

Believing that transparency in the pricing of medicines is ?fundamental? to enabling patients and stakeholders to make proper decisions about equity and value for money in health systems, the European Public Health Alliance (EPHA) called for greater pricing transparency. EPHA also called for the formation of a public website that provides comparative information on medicines? procurement prices. EPHA?s calls are a response to the European Commission?s consultation on the possible revision of Directive 89/105/EEC, which concerns the transparency of the pricing and reimbursement of medicines in various member states.

The pharmaceutical industry has been called to action by a new report that highlights the health and cost repercussions of patient noncompliance. According to Capgemini?s report, Patient Adherence: The Next Frontier in Patient Care, patient adherence to medications for chronic conditions, such as HIV and Arthritis, averages at only 50%.

Amylin Pharmaceuticals has filed a lawsuit against Eli Lilly, alleging that Lilly is engaging in "anticompetitive activity" and "breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide." According to Amylin, Lilly is planning to jointly develop and commercialize a linagliptin product with Boehringer Ingelheim that will directly compete with Amylin?s exenatide products.

J&J Announces Settlement for Corrupt Practices

sanofi Completes Genzyme Acquisition

Biosimilars Market will be Worth $3.7 Billion by 2015

EMA Challenged Over Conflict-of-Interest Case

China and India will become the world leaders in innovation during the next decade, according to an international survey released by AstraZeneca.

Sanofi-Aventis has told Genzyme to stand aside and let the shareholders decide on whether an acquisition should take place.